US Specialty Formulations (USSF) will undergo a $15 million expansion of its Lehigh Valley biopharma facility in Allentown, Pennsylvania, creating more than 100 jobs.
The expansion will bring new facility clean room suites and state-of-the-art automated packaging and product inspection equipment to the state. It will increase USSF’s clean room production capacity by more than 2.5 times and, once completed at the end of 2025, will enable the company to undertake substantially larger projects supporting growth for new and current clients.
Clean rooms are the heart of a pharmaceutical facility and are required to meet most pharmaceutical manufacturing standards. They provide a highly controlled environment essential for product quality, safety and compliance with cGMP standards. These rooms provide a sterile environment for the production of injectables, including small molecules, botanicals and vaccines.
Co-founders Dr. Kyle Flanigan, CEO, and Dr. Garry Morefield, COO, hand-built their first certified clean room at Ben Franklin Technical Incubator in 2013. This expansion will be USSF’s third generation of clean rooms, incorporating the basic cGMP and quality ideals.
The expansion is the latest in the Lehigh Valley’s growing life sciences sector. Nearly 7,000 people work at about 170 companies, including internationally recognized brands such as B. Braun Medical, Olympus, Sharp, and OraSure Technologies, another home-grown company that got its start at Ben Franklin.
“This expansion is a transformative step for USSF,” said Dr. Flanigan. “By investing in cutting-edge technology and streamlining our manufacturing processes, we are raising the bar for ourselves and reaffirming our commitment to delivering innovative pharmaceutical solutions that reduce the risk profile of new drug development or contract manufacturing and ultimately improve patient lives. This expansion empowers our dedicated team to serve our partners and clients worldwide more effectively.”